Traumatic Brain InjuryPOWERS-TBINCT04288258
A Health and Wellness Lifestyle Program to Support Community-Dwelling Persons With Traumatic Brain Injury
A study testing Telehealth-Based Health and Wellness Program (POWERS-TBI) in people with Traumatic Brain Injury, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
To evaluate the efficacy of an adapted telehealth-based, health and wellness lifestyle program on promoting healthy lifestyle behaviors and improving health outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Telehealth-Based Health and Wellness Program (POWERS-TBI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2020to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age 19 years or older
- sustained a TBI
- at least 6-months or greater out from injury
- willing to work on one or more health goals among any of the following areas of focus (e.g., health knowledge, physical activity/exercise, dietary intake/nutrition, stress management, mental activity/stimulation, social ' relationships, leisure, sleep, mindfulness/spirituality, substance use)
- able to potentially participate in physical activity or alter dietary intake, if that is a potential health goal (e.g., no medical contraindication given by their doctor)
- not currently enrolled in a health and wellness program or research study involving a health/wellness program or intervention
Show all 11Show fewer
- indicates a potential health goal to lose weight and does not independently prepare their own meals, cook, grocery shop, but has a caregiver defined by providing some type of ongoing support (emotional or instrumental) who is willing to participate as a study partner during the intervention condition
- has access to a telephone
- has regular access to the internet from a computer or laptop
- not pregnant (due to the effect on engaging in certain health promoting behaviors such as weight loss)
- does not have a significant psychiatric disorder, such as schizophrenia or bipolar disorder (those with depression or anxiety will not be excluded)
Who cannot join
- non-English speaking
- difficulty hearing
- significant problems with communication
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: A Health and Wellness Lifestyle Program to Support Community-Dwelling Persons With Traumatic Brain Injury (TBI) and Their Caregivers: In-House Research Project, Objective 2
To evaluate the efficacy of an adapted telehealth-based, health and wellness lifestyle program on promoting healthy lifestyle behaviors and improving health outcomes.
Read the detailed description
The purpose of this study is to evaluate the efficacy of an adapted telehealth-based, health and wellness lifestyle program (POWERS-TBI) on promoting healthy lifestyle behaviors and improving self-efficacy for healthy activities such as amount of physical activity, dietary/food intake, mental stimulation and activity, substance use, mindfulness/spirituality, social relationships, and/or leisure activities among persons with TBI and their caregivers. The treatment program will be delivered via the internet, along with ongoing telephone health coaching calls designed to motivate, problem-solve challenges, reinforce skills learned, and prevent relapse. The goals are to evaluate the impact of the treatment program on improving health outcomes for people with TBI. The investigators plan to accomplish this by evaluating the impact of the program using a case-control crossover design.
- Conditions
- Traumatic Brain Injury
- Being tested
- Telehealth-Based Health and Wellness Program (POWERS-TBI)
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth-Based Health and Wellness Program (POWERS-TBI)Behavioural
The treatment program is interactive and will be delivered via the internet, along with ongoing telephone health coaching calls designed to motivate, problem-solve challenges, reinforce skills learned, and prevent relapse.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Health and Wellness Program Receives: Behavioral: Telehealth-Based Health and Wellness Program (POWERS-TBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Promoting Lifestyle Profile II
HPLP-II; Total scores and subscale scores are summed and divided by number of items on each scale respectively for an average, with higher scores indicating greater lifestyle behaviors
Measured: Up to 13 months
Secondary outcomes (11)
Barriers to Physical Activity and Disability Survey
BPADS: Response choices (yes/no) for 31 items are summarized; 3 items are open-ended, higher scores indicate greater barriers
Measured: Up to 13 months
Social Support and Exercise Support for Eating and Physical Activity Habits
SSES: Subscale scores are obtained for exercise support (ranging from 10 for friends and 10 for family to 80 for friends and 80 for family); higher scores indicate greater support
Measured: Up to 13 months
Stages of Change Readiness and Treatment Engagement Scale
SOCRATES: Items are summed and averaged across each subscale: Recognition scores range from 7-35; Ambivalence scores range from 4-20; Taking Steps scale range from 8-40: Higher scores indicate greater motivation
Measured: Up to 13 months
Patient Health Questionnaire-9 Item
PHQ-9: Scores are summed and range from 0 to 27, higher scores indicate greater depressive symptomatology
Measured: Up to 13 months
Fatigue Severity Scale
FSS: Scores range from 9 to 63 with higher scores indicating greater fatigue
Measured: Up to 13 months
Bodily Pain Index
BPI: Scores for the Interference scale are summed and average for a mean (range 0 to 70) with higher scores indicating greater pain interference
Measured: Up to 13 months
Craig Handicap Assessment Reporting Technique short form
CHARTsf: Suscales scores are summed and averaged for respective scales with higher scores indicating greater community integration
Measured: Up to 13 months
Perceived Wellness Survey
PWS: A total score and subscale scores are calculated with a formula and range between 36 to 316 and average with higher scores indicating greater personal wellness
Measured: Up to 13 months
Barriers to Health Activities among Disabled Persons scale
BHADP: Ratings are summed across each item for how interfering they are with health promotion (range of possible scores 18 to 72)
Measured: Up to 13 months
Zarit Burden Scale
ZBS: Scores are summed (ranges 0 to 48) for a total scores, higher scores are indicative of greater burden
Measured: Up to 13 months
Sociodemographic Characteristics
No abbreviation: Frequencies, summed total, or averages are reported to characterize the sample
Measured: Up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Apr 2020
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- case-control crossover
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura E. Dreer, PhD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288258
- Sponsor's protocol ID
- 90DPTB0015
- Acronym
- POWERS-TBI
- Status last verified
- Oct 2023
- First submitted
- 21 Feb 2020
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will need IRB approval
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Health and Wellness Lifestyle Program to Support Community-Dwelling Persons With Traumatic Brain Injury (TBI) and Their Caregivers: In-House Research Project, Objective 2
- ClinicalTrials.gov ID
- NCT04288258
- Acronym / sponsor ID
- POWERS-TBI / 90DPTB0015
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of an adapted telehealth-based, health and wellness lifestyle program on promoting healthy lifestyle behaviors and improving health outcomes.
Detailed description
The purpose of this study is to evaluate the efficacy of an adapted telehealth-based, health and wellness lifestyle program (POWERS-TBI) on promoting healthy lifestyle behaviors and improving self-efficacy for healthy activities such as amount of physical activity, dietary/food intake, mental stimulation and activity, substance use, mindfulness/spirituality, social relationships, and/or leisure activities among persons with TBI and their caregivers. The treatment program will be delivered via the internet, along with ongoing telephone health coaching calls designed to motivate, problem-solve challenges, reinforce skills learned, and prevent relapse. The goals are to evaluate the impact of the treatment program on improving health outcomes for people with TBI. The investigators plan to accomplish this by evaluating the impact of the program using a case-control crossover design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- case-control crossover
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Telehealth-Based Health and Wellness Program (POWERS-TBI)Health and Wellness Program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- age 19 years or older
- sustained a TBI
- at least 6-months or greater out from injury
- willing to work on one or more health goals among any of the following areas of focus (e.g., health knowledge, physical activity/exercise, dietary intake/nutrition, stress management, mental activity/stimulation, social ' relationships, leisure, sleep, mindfulness/spirituality, substance use)
- able to potentially participate in physical activity or alter dietary intake, if that is a potential health goal (e.g., no medical contraindication given by their doctor)
Key exclusion criteria (3 listed)
- non-English speaking
- difficulty hearing
- significant problems with communication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth-Based Health and Wellness Program (POWERS-TBI)The treatment program is interactive and will be delivered via the internet, along with ongoing telephone health coaching calls designed to motivate, problem-solve challenges, reinforce skills learned, and prevent relapse. | Behavioural | Treatment |
Primary outcome
Health Promoting Lifestyle Profile II
Time frame: Up to 13 months
HPLP-II; Total scores and subscale scores are summed and divided by number of items on each scale respectively for an average, with higher scores indicating greater lifestyle behaviors
11 secondary outcomes
Barriers to Physical Activity and Disability Survey
Time frame: Up to 13 months
Social Support and Exercise Support for Eating and Physical Activity Habits
Time frame: Up to 13 months
Stages of Change Readiness and Treatment Engagement Scale
Time frame: Up to 13 months
Patient Health Questionnaire-9 Item
Time frame: Up to 13 months
Fatigue Severity Scale
Time frame: Up to 13 months
Bodily Pain Index
Time frame: Up to 13 months
Craig Handicap Assessment Reporting Technique short form
Time frame: Up to 13 months
Perceived Wellness Survey
Time frame: Up to 13 months
Barriers to Health Activities among Disabled Persons scale
Time frame: Up to 13 months
Zarit Burden Scale
Time frame: Up to 13 months
Sociodemographic Characteristics
Time frame: Up to 13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No. Will need IRB approval
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth-Based Health and Wellness Program (POWERS-TBI) in people with Traumatic Brain Injury, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Promoting Lifestyle Profile II (time frame: Up to 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.